Schlatter Andreas, Palkovits Stefan, Amir-Asgari Sahand, Ruiss Manuel, Zeilinger Johannes, Rotter Andreas, Schmidl Doreen, Findl Oliver
Vienna Institute for Research in Ocular Surgery (VIROS), Department of Ophthalmology, Hanusch Hospital, Vienna, Austria.
Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Int Ophthalmol. 2025 Jun 16;45(1):246. doi: 10.1007/s10792-025-03622-2.
Intense pulsed light (IPL) therapy is an approach to ameliorate meibomian gland dysfunction (MGD). A novel IPL system for the treatment of MGD is the LacryStim device. The aim of this study is to investigate the safety and efficacy of the LacryStim device in patients with MGD.
This study was conducted in a prospective, randomized, intra-individual sham-controlled, double-masked design. Three treatment visits and three study visits at baseline and after three and six months were performed. The randomized study eye (SE) was treated using 8 J/cm. The contralateral control eye (CE) was sham-treated with 1 J/cm. The primary outcome was the mean difference of meibum quality and expressibility between SEs and CEs at the six months visit.
Fifty eyes of 25 patients were included in the study. While no significant differences between both groups regarding meibum quality and expressibility could be detected at the six months visit, there was a tendency towards better expressibility in both groups after six months (SEs: - 0.4, p = 0.07; CEs: - 0.4, p = 0.04). Additionally, a significant improvement in numeric rating scale in both eyes and OSDI score (both p < 0.05) at all follow-up visits and no device-related adverse events were observed.
To our knowledge this is the first prospective evaluation of a novel IPL device. There was a significant amelioration of subjective complaints and a tendency towards better expressibility in both study and control eyes. An intra-individual design might compound the individual analysis of either eyes in studies investigating IPL.
gov Identifier: NCT05089591.
强脉冲光（IPL）疗法是一种改善睑板腺功能障碍（MGD）的方法。一种用于治疗MGD的新型IPL系统是LacryStim设备。本研究的目的是调查LacryStim设备在MGD患者中的安全性和有效性。
本研究采用前瞻性、随机、个体内假对照、双盲设计。进行了三次治疗访视以及在基线、三个月和六个月后的三次研究访视。随机研究眼（SE）采用8 J/cm进行治疗。对侧对照眼（CE）采用1 J/cm进行假治疗。主要结局是在六个月访视时SE和CE之间睑脂质量和排出能力的平均差异。
25名患者的50只眼纳入研究。虽然在六个月访视时两组在睑脂质量和排出能力方面未检测到显著差异，但六个月后两组的排出能力均有改善趋势（SE：-0.4，p = 0.07；CE：-0.4，p = 0.04）。此外，在所有随访访视中，双眼的数字评分量表和眼表疾病指数（OSDI）评分均有显著改善（均p < 0.05），且未观察到与设备相关的不良事件。
据我们所知，这是对新型IPL设备的首次前瞻性评估。在研究眼和对照眼中，主观症状均有显著改善，且排出能力有改善趋势。在研究IPL的研究中，个体内设计可能会使对任何一只眼的个体分析变得复杂。
美国国立医学图书馆临床试验标识符：NCT05089591。
